Long-Term Safety and Efficacy Evaluation of Amlitelimab in Adult Participants With Moderate to Severe Atopic Dermatitis

  • STATUS
    Recruiting
  • End date
    Oct 29, 2027
  • participants needed
    300
  • sponsor
    Sanofi
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Updated on 2 December 2022
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eczema

Summary

This is a single group, Phase 2, long-term extension study for treatment. The purpose of this study is to characterize the safety and efficacy of amlitelimab in treated adult participants with moderate to severe AD who have previously been enrolled in study KY1005-CT05 (DRI17366). Visits during the on-treatment period will be at Week 0, 1, 2, 4 and every 4 weeks (Q4W) thereafter. If remote or telephone visits are considered appropriate for participants instead of clinic visits at the timepoints indicated in the schedule of activities (SoA), home visits (e.g., home nurses, etc) will be required for administration of investigational medicinal product (IMP) and assessment of vital signs. This decision is at the discretion of the investigator.

Details
Condition Dermatitis Atopic
Treatment Amlitelimab
Clinical Study IdentifierNCT05492578
SponsorSanofi
Last Modified on2 December 2022

Eligibility

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Inclusion Criteria

Participant must be 18 years of age, inclusive, or older at the time of signing the informed consent
Participated in KY1005-CT05 (DRI17366) for moderate to severe AD and received study treatment, adequately completed the assessments required for the treatment period. Participants must only be enrolled from 1 of the following 3 groups
The first group: participants at Week 24 in the KY1005-CT05 (DRI17336) study who have not achieved an >= Eczema Area and Skin Severity Index (EASI)-75 and are Investigator Global Assessment (IGA) 2, 3 or 4
The second group: participants entering the LTE between Week 28 and Week 52 of the parent study, due to loss of clinical response in the part 2 of the parent study. Loss of clinical response is defined as the first instance of < EASI-50 during the second study period
The third group: participants at Week 24 in KY1005-CT05 (DRI17336) who have been re-randomized and who subsequently complete the study to Week 52, enter safety follow-up and experience worsening of their AD during safety follow-up or thereafter
Provide signed informed consent and able to comply with the requirements of the
protocol

Exclusion Criteria

Participants are excluded from the study if any of the following criteria
apply
Any participant who has received prohibited systemic therapies, as per KY1005-CT05 (DRI17366) clinical trial protocol, either during or after completion of KY1005-CT05 (DRI17366) will not be eligible for the long-term extension (LTE)
Participants who, during their participation in KY1005-CT05 (DRI17366), developed an adverse events (AE) or a serious adverse event (SAE) deemed related to amlitelimab, which in the opinion of the Investigator could indicate that continued treatment with amlitelimab may present an unreasonable risk for the participant
Conditions in KY1005-CT05 (DRI17366), consistent with protocol-defined criteria for permanent IMP discontinuation, if deemed related to amlitelimab or led to Investigator or Sponsor-initiated withdrawal of participant from the study (e.g., non-compliance, inability to complete study assessments, etc.)
Developed a medical condition that would preclude participation as per KY1005-CT05 (DRI17366) clinical trial protocol
Concurrent participation in any other clinical study, including non-interventional studies
Only in those participants entering after completion of KY1005-CT05 (DRI17366) safety follow-up
Newly diagnosed Tuberculosis (TB) or non-TB mycobacterial infections requiring treatment (including a positive QuantiFERON®-TB Gold blood test at the screening visit)
Positive for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb) or hepatitis C antibody (HCV Ab) at the screening visit
Laboratory values at the Screening Visit
Serum creatinine > 1.6 mg/dL (141 micromol/L) in female patients and > 1.9 mg/dL (168 micromol/L) in male patients, ii) Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >2.0 x upper limit of normal (ULN), iii) Serum total bilirubin >1.5 x ULN (except for subjects with Gilbert's syndrome, where total bilirubin must not exceed 3.0 mg/dL or 50 micromol/L), iv) In the Investigator's opinion, any additional clinically significant laboratory results from the clinical chemistry, haematology or urinalysis tests at the Screening visit
In the Investigator's opinion any significant abnormality on 12-lead ECG at the screening visit
History of or known or suspected hypersensitivity to amlitelimab or the matching
placebo formulation, or excipients used in the presentation of amlitelimab or
placebo, or in preparation for administration. History of or known or
suspected severe hypersensitivity reactions to other mAbs and/or their
excipients
The above information is not intended to contain all considerations relevant to a patient's
potential participation in a clinical trial
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